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    Summary
    EudraCT Number:2012-003072-39
    Sponsor's Protocol Code Number:41223
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-003072-39
    A.3Full title of the trial
    Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy
    Oxytocine bij PTSS: Effectiviteit als toevoeging bij Narratieve exposure therapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxytocin in PTSD: Effectiveness in addition to psychotherapy
    Oxytocine bij PTSS: Effectiviteit als toevoeging aan psychotherapie
    A.3.2Name or abbreviated title of the trial where available
    Oxytocin in PTSD: Effectiveness in addition to NET (OPEN)
    Oxytocine bij PTSS: Effectiviteit als toevoeging bij NET (OPEN)
    A.4.1Sponsor's protocol code number41223
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Center, University of Amsterdam
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademic Medical Center, University of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center, University of Amsterdam
    B.5.2Functional name of contact pointOlff- Oxytocin research group
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 5
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.vanzuiden@amc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Syntocinon, nasal spray 40 IU/ml
    D.2.1.1.2Name of the Marketing Authorisation holderDefiante Farmacêutica, SA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Nasal drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Posttraumatic stress disorder
    Posttraumatische stress stoornis
    E.1.1.1Medical condition in easily understood language
    posttraumatic stress disorder
    posttraumatische stress stoornis
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036316
    E.1.2Term Post-traumatic stress disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the effectiveness of the administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) in reducing PTSD and co-morbid depressive symptoms in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a reduction in PTSD and depressive symptoms over the course of the treatment, but that the reduction in symptoms will be faster and larger in the oxytocin group.
    Primaire vraagstelling van deze studie is om de effectiviteit van oxytocine te onderzoeken in vergelijking met placebo
    als een toevoeging aan exposure sessies (NET) in de behandeling van PTSS. We veronderstellen dat het toevoegen van
    oxytocine aan exposure in NET de afname in symptomen van PTSS versnelt en vergroot in vergelijking met placebo. Eveneens wordt verondersteld dat de afname in co-morbide depressieve symptomen sterker zal zijn in de oxytocine groep.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate whether administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) is more effective in dampening stress reactivity in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a dampening of both self-reported and physiological stress-reactivity (heart rate, heart rate variability, salivary cortisol), but that the dampening of stress reactivity will be faster and larger in the oxytocin group.
    Secundaire vraagstelling is om te onderzoeken of oxytocine toevoeging aan NET bij PTSS leidt tot een sterkere verandering in stress reactiviteit dan wanneer placebo wordt toegevoegd. Verondersteld wordt dat het toevoegen van oxytocine zal leiden tot een sterkere en snellere afname van subjectieve en fysiologische stress reactiviteit dan wanneer placebo wordt toegediend.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a diagnosis of chronic PTSD (> 3 months)
    -CAPS score of 50
    -Age 18-65 years
    -Written informed consent
    - Patienten met een diagnose van chronische PTSS (> 3 maanden)
    -CAPS score 50
    -Leeftijd 18-65 jaar
    -Schriftelijke toestemming
    E.4Principal exclusion criteria
    -Suicidal risk.
    - Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, or excessive substance related or eating disorder over the past 6 months.
    - Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month).
    - Female patients with an active pregnancy wish.
    - Female patients giving lactation to their child.
    - Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent).
    - An organic disorder/cognitive impairment.
    - Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used.
    -Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers.
    -Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat)
    -Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year.
    -Suicide risico
    -Aanwezigheid van één van de volgende DSM IV diagnoses, op het moment of in het verleden: psychotische stoornis, incl, schizofrenie, een bipolaire stoornis, of ernstige verslavingsproblematiek of eetstoornis in de afgelopen 6 maanden
    -Zwangere vrouwen (vrouwelijke patienten in hun vruchtbare levensfase moeten een negatieve
    zwangerschapstest hebben, deze wordt elke maand herhaald)
    -Vrouwelijke patienten met een actieve zwangerschapswens
    - vrouwelijke patienten die borstvoeding geven
    - diagnose van ernstige depressieve stoornis (met psychotische trekken en/of hoge suicide intentie)
    -Een organische aandoening of cognitieve beperking
    - patienten die psychotrope medicatie gebruiken zullen minstens twee maanden voorafgaand aan de voormeting (een stabiele dosis moeten gebruiken. Psychotrope medicatie die al tijdens de voormeting wordt gebruikt zal worden gehandhaafd tot de nameting. Tijdens de studie zal geen psychotrope medicatie worden voorgeschreven tenzij er ernstige depressieve symptomen ontwikkeld worden. Er zal een medicatie protocol gebruikt worden dat overeenkomt met klinische richtlijnen (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005).
    - Het gebruik van bepaalde medicatie: prostaglandines, bepaalde anti-migraine medicatie (ergot alkaloides), bèta-adrenerge recepterblokkerende middelen en systemische glucocorticoiden;
    - Overgevoeligheid/allergie voor oxytocine of de bestanddelen (bv methylhydroxybenzoaat en
    propylhydroxybenzoaat)
    - Aanwijzingen voor klinisch significante,onstabiele medische toestand, waarbij een contraindicatie bestaat voor toediening van oxytocine, zoals cardiovasculaire, gastro-intestinale, pulmonaire, renale, endocriene of hematologische stoornissen, glaucoom, epilepsie in de anamnese, of een beroerte of myocardinfarct in het afgelopen jaar.
    E.5 End points
    E.5.1Primary end point(s)
    Primary study endpoints are levels of PTSD and co-morbid depressive symptoms. PTSD symptoms will be assessed by means of clinical diagnostic interviews (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and self-report questionnaires (Impact of Events Scale-Revised, measured at all assessment points). Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session).
    Primaire uitkomstmaten zijn de ernst van PTSS en co-morbide depressieve symptomen. PTSS zullen worden gemeten met behulp van een klinisch diagnostisch interview (CAPS, afgenomen op voormeting en nametingen 1-3 en 14-16 weken na laatste NET sessie) en vragenlijst (IES-R, afgenomen op alle meetmomenten). Depressieve symptomen zullen worden gemeten met behulp van een vragenlijst (BDI, afgenomen op voormeting en nametingen 1-3 en 14-16 weken na laatste NET sessie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After each NET session, and 1-3 and 14-16 weeks after the final NET session
    Na elke NET sessie, en 1-3 en 14-16 weken na de laatste sessie
    E.5.2Secondary end point(s)
    Secondary study endpoints are measures of stress-reactivity, both self-reported (Perceived Stress Reactivity scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session).
    Secundaire uitkomstmaten zijn maten van stress-reactiviteit, zowel zelf-gerapporteerde (PSRS, gemeten op voormeting en nameting 1-3 en 14-16 weken na laatste NET sessie) als fysiologische stressreactiviteit (hartslag, hartslag variabiliteit, speeksel cortisol, gemeten na afloop van elke NET sessie).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each NET session, and at 1-3 and 14-16 weeks after the final NET session
    Na elke NET sessie, en 1-3 en 14-16 weken na de laatste NET sessie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from standard care; participants will continue into the next phase of treatment for PTSD (resocialization)
    Niet verschillend van standaard zorg: deelnemers zullen doorstromen in de volgende fase van de behandeling voor PTSS (resocialisatie)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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